End Pre-Emption, Support The Medical Device Safety Act

By alexchasickMarch 18, 2009

Two recent Supreme Court cases on federal pre-emption have made a mess of tort law, confusing and endangering consumers by holding that a patient who is injured by a dangerous drug can sue the manufacturer, but a patient injured by a dangerous medical device cannot. How this happened, and what to do about it, inside.

The recently decided Wyeth v. Levine held that a patient who was harmed by a poorly labeled drug (in this case, an anti-nausea drug whose label specified several ways it could be administered, one of which could, and did, cause gangrene and amputation) could sue the drug maker for failing to warn medical staff of the dangers of the drug.

On the other hand, the Court in Riegel v. Medtronic held that a patient injured by a poorly designed and labeled medical device (in this case, a heart catheter that exploded and killed the patient) could not sue the device maker.

The question in both of these cases was whether the FDA’s approval of a drug or device should be enough to shield (pre-empt) the manufacturer from liability, even when the manufacturer knew of the dangers. Considering howdysfunctional the FDA is, and how unscrupulous drug and device manufacturers can be, we’re not comfortable leaving things entirely up to them.

Neither is Congress, which has introduced the Medical Device Safety Act. The MDSA simply reverses the Court’s decision in Riegel and holds that state law regulating medical devices will be upheld. The bill has attracted bipartisan support and already has 69 cosponsors in the House. Now the New England Journal of Medicine has gotten involved and endorsed the MDSA in its latest issue:

Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts.

We agree. Injured consumers deserve justice, and that means being able to have their day in court. Here’s how to contact your representative and senators to ask for their support.

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There are more issues here than just people “deserving justice”. Medical devices are already outrageously expensive, and I’m not so sure that allowing different regulations at the level of every individual state is going to do much to help that situation. It would appear (though I’m not a lawyer, and may be misreading this) that what is actually at issue in this case was whether people could sue under STATE LAWS that differ from the federal requirements, not whether people could sue at all. I think the device makers would still be liable if they were negligent under federal rules, if I understand correctly. If so, I don’t necessarily agree that “ending preemption” would be a good idea.

@johnva: Oh, and I should add that I don’t think the FDA is perfect, nor is their process for addressing grievances in approved products. But I don’t think the way to fix that is to allow states to impose whatever requirements they want. That might be a win for the small percentage of people that are actually injured by approved medical devices, but it could be a big loss for the much larger group of people who are already having trouble affording these devices if it ends up driving up costs. The way to fix this is to make the FDA better and give people a better way to sue in federal court rather than opening it up to states.

@johnva: From what I read, people can sue if the end product doesn’t match the requirements and specifications approved by the FDA. So any variance not evaluated originally by the FDA, such as a manufacturing failure isn’t shielded from suits. Only when devices fail within established tolerances and failure rates are lawsuits prevented.

@Corporate_guy: OK, thanks for clarifying. That’s what I thought, and I think that is reasonable. In that case, I am completely against this proposed legislation. I still think the FDA might need some reform, though.

I would say if a device explodes and it’s not supposed to that the manufacturer can be sued under most circumstances. I can understand if it was being misused though. I don’t really think a medical device should be held to a different standard than any other devices out there either.

Does this allow patients to sue in the case where natural risk is the cause. Such as a failure of electronic component? All electronics have error rates and failure rates. It would be impossible to guarantee that an electronic component won’t fail 5 minutes after being inserted into a patient.

The same logic probably applies to anything with moving parts.

There has to be a standard that when met protects manufacturers from lawsuits. Otherwise the costs of medical devices are going to skyrocket and some devices may never be made.

@gStein: And this proposal would likely make them even MORE expensive than that, even for totally legit and non-negligent companies, just due to the need to comply with a mosaic of different state law requirements. The more I think about it, the more I think this legislation is horrible idea. I think that the Consumerist blew it on this one.

Injured customers can complain to their representatives in Congress if they feel stricter regulation of medical devices is needed. It’s unfortunate that some people are injured by the failure of the very devices that are supposed to keep them healthy, but we have to keep in mind that the more lawsuits we allow against these companies, the less resources they’ll have available for research and development of new and improved medical devices.

I think the current solution is the most workable one, where the FDA defines an acceptable safety standard and the device has to be proven to live up to that standard before being distributed to the public. It’s impossible to guard against any and all defects, and in the medical industry having resources for research is critical, so we shouldn’t make these companies into the insurers of their products. We would all suffer if that occurred.

A couple of points that need to be made –
1. FDA Preemption for medical devices has been around for about 2 years. Product Liability lawsuits for 70 years. To say that suddenly, without preemption, manufacturers are going to have an unbearble burden is misleading at best.
2. With FDA Preemption there is much less incentive for a manufacturer to honestly pursue the most safe product.
3. Pharmaceutical companies, both drug and device, have proven one thing for sure – they are not beyond deceptive business practices in pursuit of profit.
4. The FDA, who the manufacturers want to rely on to be the last word on safety, have admitted that they are ill equipt and unable to insure the drug/device consumer’s safety.

All of this said, we can not allow a manufacturer – of any kind – the freedom from having to come face to face with an allegedly harmed consumer in a court of law.

As it is, the FDA takes MUCH longer to approve medical devices than most of the world. Products for the USA usually come out after they have been on the market in Europe for several years. The only country that takes longer is Japan. This is one of the things that makes them so much more expensive in the USA. We get old technology that the companies have had to spend millions more dollars testing before they get to sell anything here. Now we want to make the states have their own regulations and let people on juries who have avoided science their entire lives decide this. If you thought medical technology was expensive before…

This would not protect consumers, but it would stop a lot of promising technologies from coming to market. If we want to toughen regulations, it needs to be done through the FDA. I am certain they need more resources and funding, so we should do it that way instead of some reactionary crap legislation that will hurt and not help at all.

The main issue here is that devices will fail. There is no way to prevent this. The only recorse is to legislate around a standardized failure rate of say .25% or less. If a device exceeds this failure rate that the protections of the court are lost and a class action suit can proceede.

I can see a number of ways this idea can be abused but it seems like a good overall basis to work from.

@Munchie: I don’t think any blanket absolute failure rate should be legislated. A reasonable failure rate for one type of device would be unreasonable for some others. That should be a regulatory matter for an agency like the FDA, not Congress, where it is evaluated on a case-by-case basis. A pacemaker should probably have a failure rate of damn near zero, but for something like carbon fiber leg braces (I wear these because of muscle atrophy due to a neurological disease) the failure rate is almost irrelevant as long as the company has a decent warranty.

My understanding is that you CAN’T sue under federal law; thats the point of the FDA Pre-Emption. What has happened is that states have attempted an end run around this by enacting their own laws. These were subsequently struck down in Riegel, because the original medical devices act from the 70’s is rather clear; state regulations were to be swept aside and replaced by federal laws, and that meant liability under consumer laws in those states go down as well.

Now Congress is making explicit that the original medical devices act does not get one off the hook for liability vis a vis state consumer laws. As the way it should be. Every other product falls under such laws, and theres no reason to expect medical devices should be the exception.

Ok. Im lost. How was this decision a good thing? How can a jury decide that it knows more about what should and should not go on a medicine bottle than actual trained doctors? To me this basically says “We don’t care about your credentials. We don’t care that you know more than we do about a subject. We just think you are wrong.” This guy put it a lot better then I ever could. [reason.com]

It’s also about preventing people from suing under general causes of action, like negligence.

Federal agencies aren’t perfect. They can be unduly affected by industry players, and I think this is even moreso true with the FDA than others.

And, with preemption, you’re kind of at the whim of the current sitting president. I’m sure the EPA has a completely different agenda under Obama than Bush. A medical device that would have passed muster under a Republican president might not be safe enough under a Democrat.

@Myownheroine: That may be so, but a) I think that general causes of action SHOULD be limited in the specific case of highly regulated medical devices, simply because it’s inevitable that some of them will fail and the manufacturers need some protection or no medical devices will be sold at reasonable prices here; and b) I still think that allowing states to have their own patchwork of regulations is a horrible idea. You would end up hurting many more people than you helped.

Is the FDA or any other government regulatory agency perfect? No, and no one is claiming they are. Of course there is some degree of influence over them by industry, and of course that’s going to be different depending on who is running the place. That’s unavoidable, but this is still a horrible idea. The solution is to fix the FDA. In the case of medical devices, I think that they already do a pretty good job as most of them are pretty safe. Cost of the devices associated with all our regulation is much more of a problem than their safety in this country, so we don’t need to go even further down that road. Again, you could legislate that 0% failure is acceptable and give people the right to sue if any device ever failed, but you would just end up increasing the cost of every medical device to the point that lots of people wouldn’t be able to afford them.

qwerty is right, the Levine decision was total BS. Those labels have strict oversight from the FDA, and Wyeth’s labeling was approved by that regulatory government agency. If there was a problem with their label, the FDA is responsible. Wyeth certainly shouldn’t be punished for using officially approved labeling.

Let me put it this was, if you have a pacemaker that fails (killing you) and because FDA said that it was safe, then you can’t sue. Even though it short-circuited and the maker, who knew it could short-circuit in a tiny amount of cases, but also knew that the FDA was unlikely to discover this failure in its tests either because the failure rate is so small or because the FDA doesn’t realize that this failure is likely or possible. You people don’t think you should be able to sue?

If I buy a TV, I expect it to work. And if Sony has to make it more expensive for it to work, then so be it. And I definitely want something my health depends on to work!

I guarantee you, a small town senator isn’t going to introduce and pass a bill regarding fatigue in plastics in pacemakers in the SD legislature.

@Myownheroine: The pacemaker example is essentially hyperbole. Most medical devices aren’t such a life or death thing, for one thing. And I have NEVER said you shouldn’t be able to sue…I just think that there should be limits to what grounds you can sue under. You should not be able to sue on the grounds of something the FDA approved as acceptable.

And I just totally disagree with your “so be it” logic on increasing costs. Again, doing that would directly harm more people than it would help. Perfect safety is impossible under any reasonable costs (and like I said, most devices are not as safety-critical as a pacemaker). Some protections for manufacturers are needed to keep costs under control, so that more people can actually benefit from medical technology. Let me repeat this: our devices are already very safe and among the most highly regulated and expensive in the world. Why do we need to make them even more expensive and more highly regulated (and inconsistently regulated), helping a tiny percentage of people at the expense of a much larger group (the majority that don’t have dangerous problems with their medical devices)?

@Myownheroine: In the pacemaker case you pointed out, it is the FDA that should be held responsible unless the manufacturer intentionally duped them into approval through withholding information or some other form of deceit. If the manufacturer presents the device for approval legally, with all required documentation, it doesn’t make sense to hold them responsible. That is the whole point of regulatory agencies like the FDA.

If the FDA approves a device or substance safe to market, the manufacturer has taken every legally required safety measure. If there are gaps there, it is the regulatory agency’s problem.

@Rhayader: Thank you. You said it better than I did. People are painting this as if there are no safety checks on medical devices if we aren’t allowed unlimited rights to sue them, and this just isn’t so. There are still grounds under which regulated manufacturers can be sued, but there are also reasonable limits.

The FDA has already said that they are incapable of over-seeing & regulating all new medical devices on the market of which there are 1,000’s. FDA Preemption was never intended by Congress and the Medical Device Safety Act should be passed to protect innocent lives and the citizens of the US.

@ClarenceAttis:
So, who is going to pay for that life saving device that I might need but could in no way afford because of the companies having to spend big bucks on lawsuits. Or better yet, when people die because new, life saving technologies are not developed because it is too risky.

As a victim of a class III medical device for which the FDA did not require them to list 2 highly toxic ingredients in the injected gel/liquid, I am outraged by this lack of accountibility. After telling my doctor in numerous ways, numerous times that I am highly sensitive to chemicals, that trained physician still chose to inject a “medical device” that was known to cause more reactions than other choices available. As a diligent and highly educated patient, I read through the patient information sheet and web site of the pharmaceutical company, and they did NOT disclose the presence, even in permissible levels, of these highly carcinogenic and toxic chemicals. I was not given all of the information to make an “informed consent.” My doctor obviously did not have my best interest in mind, and I am still suffering, over a year out since this injection.

And guess who threw me “under the bus”…my doctor and my insurance company…as well as the makers of this device. I am not alone in the extended and life-threatening reaction from this product, and those “in charge” are doing nothing to warn future patients. So if you’re on the side of pre-emptive protection, you have obviously not been injured by a medical device when not given all the information you should be given…You have obviously not suffered to near death when trusting those “educated” to make these decisions in your best interest. And the FDA is NOT on the side of the consumer. The powers that be are on the side of BIG money. Period.

The makers of medical devices and drugs need more accountibility than the FDA.

As a victim of a class III medical device for which the FDA did not require them to list 2 highly toxic ingredients in the injected gel/liquid, I am outraged by this lack of accountibility. After telling my doctor in numerous ways, numerous times that I am highly sensitive to chemicals, that trained physician still chose to inject a “medical device” that was known to cause more reactions than other choices available. As a diligent and highly educated patient, I read through the patient information sheet and web site of the pharmaceutical company, and they did NOT disclose the presence, even in permissible levels, of these highly carcinogenic and toxic chemicals. I was not given all of the information to make an “informed consent.” My doctor obviously did not have my best interest in mind, and I am still suffering, over a year out since this injection. And guess who threw me “under the bus”…my doctor and my insurance company…as well as the makers of this device. I am not alone in the extended and life-threatening reaction from this product, and those “in charge” are doing nothing to warn future patients. So if you’re on the side of pre-emptive protection, you have obviously not been injured by a medical device when not given all the information you should be given…You have obviously not suffered to near death when trusting those “educated” to make these decisions in your best interest. And the FDA is NOT on the side of the consumer. The powers that be are on the side of BIG money. Period. The makers of medical devices and drugs need more accountibility than the FDA. PS…I use to be on the other side.